A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01858792
• Date of registration: 19/12/2012
• Prospective Registration: No
• Primary sponsor: Human Genome Sciences Inc., a GSK Company
• Public title: A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies
• Scientific title: Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients With Higher Disease Activity (Anti-dsDNA Positive and Low Complement): A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies
• Date of first enrolment: May 2011
• Target sample size: 1
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01858792
• Study type: Observational
• Study design: N/A
• Phase: N/A

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Clinical diagnosis of SLE by ACR criteria.

- Active SLE disease.

- Autoantibody-positive.

- On stable SLE treatment regimen.

Exclusion Criteria:

- Pregnant or nursing

- Have received treatment with any B cell targeted therapy.

- Have received treatment with a biological investigational agent in the past year.

- Have received IV cyclophosphamide within 180 days of Day 0.

- Have severe lupus kidney disease.

- Have active central nervous system (CNS) lupus.

- Have required management of acute or chronic infections within the past 60 days.

- Have current drug or alcohol abuse or dependence.

- Have a historically positive test or test positive at screening for HIV, hepatitis B,
or hepatitis C.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lupus Erythematosus, Discoid

Intervention(s)

Drug: Belimumab 10 mg/kg

Drug: Belimumab 1 mg/kg

Other: Placebo

Primary Outcome(s)

SLE (systemic lupus erythematosus) Response Index (SRI) at Week 52 [Time Frame: Response rate by visit through Week 52 for the pooled studies and through Week 76 for Study C1056]

Secondary Outcome(s)

Percent of Subjects with Daily Prednisone Dose Increased to > 7.5 mg/day from =7.5 mg/day at Baseline by Visit [Time Frame: For pooled studies through Week 52.]

EQ-5D (EuroQol five dimension self-reported health state questionnaire) visual analogue scale (VAS) score using value set for the UK [Time Frame: Change from baseline by visit up to Week 52]

Improvement in each SELENA SLEDAI (Safety of Oestrogen in Lupus National Assessment Systemic Lupus Erythematosus Disease Activity Index) organ domain [Time Frame: At week 52]

Mean change in SF-36 (Short Form 36 Health Survey questionnaire) domains (population a only), Physical Component Summary (PCS) and Mental Component Summary MCS (population a only) [Time Frame: By visit up to Week 52]

All BILAG A (British Isles Lupus Assessment Group) Flares will be assessed for population a [Time Frame: In periods of Weeks 0-52 and Weeks 24-52]

The percent of subjects with no new BILAG A (British Isles Lupus Assessment Group) organ domain score or 2 new BILAG B organ domain scores [Time Frame: By visit up to Week 52 for pooled studies]

Mean change in PGA (Physician's Global Assessment) [Time Frame: At Week 24, and by visit up to week 52 (population a only).]

Time to first BILAG organ improvement by organ domain, among subjects with involvement at baseline [Time Frame: Over Weeks 0-52]

The response rate by visit modified to exclude anti-dsDNA and complement items in the determination of a 4-point reduction in SELENA SLEDAI (Safety of Oestrogen in Lupus National Assessment Systemic Lupus Erythematosus Disease Activity Index). [Time Frame: By visit up to Week 52 for pooled studies.]

Time to first SELENA SLEDAI (Safety of Oestrogen in Lupus National Assessment Systemic Lupus Erythematosus Disease Activity Index) organ improvement by organ domain, among subjects with involvement at baseline [Time Frame: Over Weeks 0-52]

EQ-5D (EuroQol five dimension self-reported health state questionnaire) index score using value set for the UK [Time Frame: Change from baseline by visit up to Week 52]

Percent of subjects with no worsening in PGA (Physician's Global Assessment) [Time Frame: By visit up to Week 52]

The response rate calculated without allowable and prohibited medication rules applied (population a only). [Time Frame: By visit up to Week 52]

All Flares and Severe Flares will be assessed for population a [Time Frame: In periods of Weeks 0-52 and weeks 24-52]

Percent of subjects with greater than 4 point reduction from baseline in SELENA SLEDAI (Safety of Oestrogen in Lupus National Assessment Systemic Lupus Erythematosus Disease Activity Index) [Time Frame: By visit up to Week 52]

Mean change in FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale score [Time Frame: By visit up to Week 52]

EQ-5D (EuroQol five dimension self-reported health state questionnaire) individual item score (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) [Time Frame: Change from baseline by visit up to Week 52]

Percent of Subjects with Daily Prednisone Dose Reduced by =25% and to = 7.5 mg/day from > 7.5 mg/day at Baseline by Visit [Time Frame: For pooled studies through Week 52]

Percent of Subjects with Daily Prednisone Dose Reduced to = 7.5 mg/day from > 7.5 mg/day at Baseline by Visit [Time Frame: For pooled studies through Week 52]

Secondary ID(s)

115030

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline